cpereira@noblefcm.com, Author at Channelchek

GeoVax Labs (GOVX) – CRO Partnership For Clinical Trial Allows Sponsored Phase 2b Trial To Move Forward

Posted on June 28, 2024June 28, 2024 by cpereira@noblefcm.com

Friday, June 28, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Partnership For BARDA-Funded Trial Announced. GeoVax announced a partnership with Allucent, a global clinical management organization (CRO), to conduct the Phase 2 clinical trial for CM04S1. The trial has been awarded approximately $357 million in funding through Project NextGen, with about $24.3 million going to GeoVax and the balance to fund the clinical trial costs. We see the partnership as an important step toward the start of the clinical trial, as well as another scientific validation for CM04S1 and the GeoVax manufacturing technologies.

The Partnership Allows The Trial To Begin As Expected. Under the grant, GeoVax is the trial sponsor with responsibility for manufacturing and providing vaccine supplies. The grant also requires a CRO to conduct the trial and manage its clinical operations. The announcement of the partnership with Allucent, a global CRO that can provide these services, allows the trial to move forward with a possible starting date during summer 2024.

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The GEO Group (GEO) – A Resolution for Lawton

Posted on June 27, 2024June 27, 2024 by cpereira@noblefcm.com

Thursday, June 27, 2024

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Resolution. In a quick turnaround, The GEO Group and the State of Oklahoma Department of Corrections (ODOC) reached an agreement on a one-year contract to continue operating the Lawton Correctional and Rehabilitation Facility (LCRF) through June 2025. The Board of Correction approval allows the contract to move forward in the process to be approved by the Attorney General’s office and executed by ODOC.

Changes. As part of the agreement, ODOC will reduce the number of inmates housed at LCRF to 2,388 from a current 2,616. With the population reduction, GEO has pledged to actively work to reduce violence, provide more access to programs, and grant more out-of-cell time for the inmates.

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Comtech Telecommunications (CMTL) – New Award from Texas

Posted on June 27, 2024June 27, 2024 by cpereira@noblefcm.com

Thursday, June 27, 2024

Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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New Contract. Comtech announced the Company has been awarded a contract from North Central Texas Emergency Communications District to provide NG911 services. The Company will be assisting in further modernizing the district’s infrastructure. The contract carries a five-year base award with three two-year option periods, and a maximum value of $30 million.

Continued Relationship. The district’s contract with Comtech continues an established relationship of over 10 years. Currently, the Company provides call routing and call handling technologies and serves over two million people in the state of Texas. With the contract, the district will have the ability to fully migrate to a new NG911 system, and the Company will also help in enhancing the region’s call routing capabilities.

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Unicycive Therapeutics (UNCY) – The Moment We’ve Been Waiting For: OLC Pivotal Trial Meets Endpoints For Phosphate Control

Posted on June 26, 2024June 26, 2024 by cpereira@noblefcm.com

Wednesday, June 26, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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Side Effect Rates Were Low. Unicycive announced top-line results from its pivotal study to determine OLC (oxylanthanum carbonate) tolerability, safety, and dosing. The trial met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. An NDA filing is expected in 3Q24.

Low Discontinuation Rate Met The Primary Endpoint. Tolerability, the rate of discontinuations due to treatment related adverse events (TRAEs), was the primary endpoint. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, a rate of 1.4%. In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.

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Bit Digital (BTBT) – AI Contract Expansion Finalized

Posted on June 26, 2024June 26, 2024 by cpereira@noblefcm.com

Wednesday, June 26, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Finalized Terms. Yesterday, Bit Digital announced the Company finalized an agreement to supply its anchor AI client with an additional 2,048 GPUs. With the expansion, the client will now be supplied 4,096 GPUs. The contract now has total revenue of approximately $275 million, or $92 million on an annualized basis.

Purchasing More Servers. Bit Digital is purchasing 256 servers from Dell Technologies with a total of 2,048 Nvidia HGX H100 GPUs. Expected to be delivered in July 2024, the servers will be deployed to the Company’s Iceland datacenter and are expected to start generating revenue in August 2024. Management intends to finance the purchase with a mixture of cash and digital assets, and has entered into a sale-leaseback agreement for 1,024 of the GPUs with a third party entity. Recall, management previously noted an additional $60 million of capital would be needed for the purchase.

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NN, Inc. (NNBR) – A CFO Change

Posted on June 25, 2024June 25, 2024 by cpereira@noblefcm.com

Tuesday, June 25, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A CFO Change. Yesterday, NN, Inc. announced the appointment of Chris Bohnert as Chief Financial Officer, effective June 25, 2024. Mr. Bohnert assumes the position from Mike Felcher, who will stay on as a consultant, most likely through the second quarter reporting season.

Why? In a word, experience. According to management, NN needed a “been there, done that” to of finance person and Mr. Bohnert’s background fit the bill. Mr. Bohnert had been working with NN on an advisory basis in the refinancing process and previously worked with CEO Harold Bevis at Commercial Vehicle Group (CVG). We believe his appointment will enable CEO Bevis to push for faster change, both operationally and financially.

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Maple Gold Mines (MGMLF) – Restructuring Transaction Provides a Clear Path to Development

Posted on June 25, 2024June 25, 2024 by cpereira@noblefcm.com

Tuesday, June 25, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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JV restructuring transaction. Maple Gold and Agnico Eagle Mines Limited (NYSE: AEM) entered into an agreement pursuant to which: 1) the existing joint venture agreement dated February 2021 between Agnico and Maple will be terminated, 2) Maple will obtain a 100% ownership interest in the Douay Gold and Joutel Gold Projects, 3) Maple will grant Agnico a 1.0% net smelter return royalty associated with the properties, and 4) Agnico Eagle will retain certain options to acquire a 50% ownership interest in the projects.

Agnico back-in option. Agnico’s option to acquire a 50% interest in the projects will be exercisable by Agnico following the closing of the restructuring transaction until 90 days following receipt of a notice from Maple Gold that its board of directors has authorized the development of a mine complex at the project. The mine will need to be supported by a preliminary feasibility study or feasibility study affirming a C$300 million net present value. If the option is exercised, Agnico will be required to make a cash payment to Maple Gold equal to 200% of expenditures incurred by Maple Gold, along with C$12 million.

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Comstock Inc. (LODE) – Comstock Metals Receives Conditional Use Permit for its First Planned Industry Scale Facility

Posted on June 25, 2024June 25, 2024 by cpereira@noblefcm.com

Tuesday, June 25, 2024

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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Taking the next step. The company’s demonstration facility has enabled the acceleration of the design and permitting of the first industry scale facility targeting 100 thousand tons per year of waste solar panel processing capacity. Comstock Metals is engaged with major, large-scale customers for high-volume, longer-term commitments that will be able to be serviced with expanded storage capacity and a planned industry-scale site.

Conditional use permit. The Lyon County, Nevada Board of County Commissioners unanimously approved a conditional use permit for the operations and material storage of solar panels at Comstock Metals first planned industrial scale facility in Silver Springs, Nevada. The facility will serve the expanding solar industry in the western United States. Once the company demonstrated its ability to recycle and reuse 100% of the recycled materials, it accelerated permitting for the expansion, both for storage and industry-scale operations.

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Vince Holding Corp. (VNCE ) – Fashioning A Growth Company

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

500 5th Avenue 20th Floor New York, NY 10110 United States Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 599 Key Executives Name Title Pay Exercised Year Born Mr. Jonathan CEO & Director 825.62k N/A 1958 Ms. Marie Fogel Senior VP and Chief Merchandising & Manufacturing Officer 633.19k N/A 1961 Mr. John Chief Financial Officer

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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Initiating coverage. The company appears to be well on its way toward favorable revenue growth and improving margins, along with a healthier balance sheet. We believe that investors have not yet caught up to the story of the company’s transformation. We are initiating coverage with an Outperform rating and a $3 price target.

Attractive position in the fashion industry. The company offers luxury, high quality men’s and women’s apparel that is in a fashion growth category of sophisticated, unstructured, casual wear. We believe that there is a significant price umbrella with other designer brands that should allow the company to reduce discounting, raise prices and increase its market share in the premium brand space.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

The GEO Group (GEO) – A Contract Termination

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Lawton Termination. GEO announced the discontinuation of its contract with the Oklahoma Department of Corrections for the company-owned, 2,600-bed Lawton Correctional and Rehabilitation Facility, which is set to expire on June 30, 2024, unless extended for an additional three months under terms proposed by GEO.

Why? In our discussions with management, the facility is not performing up to GEO expectations due to inadequate current funding levels provided by the State and difficulty in attracting sufficient staffing, a problem across the State DOC. GEO noted a closure would not have a material impact on financial guidance for 2024. It is our view that by providing notice to the State, GEO is hopeful a realistic funding solution can be found with the State, either as currently operated or, potentially, with GEO entering into a lease of the facility with the State operating the facility.

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Graham Corp. (GHM) – Mission Critical Supplier With Solid Growth Prospects

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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Initiating Research Coverage. We are initiating research coverage of Graham Corporation with an Outperform rating and a $35 price target. GHM is a provider of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries. The Company’s expanding business with the defense industry, specifically the U.S. Navy, has reduced cyclicality, while enabling the Company to target other, high growth end markets.

Improving Margins. With the completion of first order units for the U.S. Navy and the implementation of a strategic plan, Graham is well positioned to drive increased profitability. In fiscal 2024, gross margin expanded by 570 bp to 21.9%, which is expected to grow to 22%-23% in fiscal 2025.

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Tonix Pharmaceuticals (TNXP) – Tonix Announces Positive Pre-NDA Meeting – NDA Submission On Schedule

Posted on June 21, 2024June 21, 2024 by cpereira@noblefcm.com

Friday, June 21, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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NDA For Tonmya Expected In 2H24. Tonix announced that it has received written feedback from the FDA from its pre-NDA meetings. The meetings covered the CMC (chemistry, manufacturing, and controls) section of the Tonmya new drug application (NDA). Based on the written feedback, Tonix believes it is in alignment with the FDA on important issues. This keeps the NDA filing on schedule for submission in 2H24.

Tonix Reaches CMC Agreement and Alignment. Topics of the meetings included the proposed drug substance and commercial specifications, shelf-life assignment, manufacturing, and commercial drug packaging. We see this as a significant milestone toward the NDA submission and approval, as many NDA applications have been delayed or received Complete Response Letters (CRLs) due to issues with manufacturing and the CMC section.

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Cocrystal Pharma (COCP) – Cocrystal Updates Studies On Influenza and Bird Flu

Posted on June 21, 2024June 21, 2024 by cpereira@noblefcm.com

Friday, June 21, 2024

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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Potential Efficacy Against A New Strain Of Avian Influenza. Cocrystal has announced that studies of its influenza drug, CC-42344, have shown efficacy against the new avian influenza strain H5N1. Cocrystal has used its proprietary technology to determine the strain’s mutations and structure, then conduct preliminary tests. The binding site for CC-42344 was not changed and can block reproduction of the new strain, making it an effective vaccine against the virus.

Avian Influenza Strain Has Begun To Infect Humans. Avian influenza H5N1 has caused significant illness in commercial bird flocks since 2003. Its impact was limited until recent outbreaks in dairy cattle and infections in diary workers. This ability to mutate and infect other species is a significant step toward causing widespread outbreaks in humans, elevating it to a public health concern.

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